510(k) K882571
K882571 is an FDA 510(k) premarket notification submitted by Whitehall Laboratories, Inc. for the device "KOLYNOS DENTAL FLOSS". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Whitehall Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1988
- Date Received
- June 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Floss, Dental
- Device Class
- Class I
- Regulation Number
- 872.6390
- Review Panel
- DE
- Submission Type